BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    MDR report key: 5404033 · Received February 2, 2016

    Report

    Report Number
    3005168196-2016-00110
    Event Type
    Malfunction
    Date Received
    February 2, 2016
    Date of Event
    January 5, 2016
    Report Date
    January 5, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548013961
    PMA / PMN Number
    K142458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2016-00109, 2. 3005168196-2016-00111.

    Additional Manufacturer Narrative · 1

    RESULTS: THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) WAS KINKED APPROXIMATELY 81.0 CM FROM THE HUB AND STRETCHED FROM APPROXIMATELY 108.0 CM FROM THE HUB TO THE DISTAL TIP. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICES REVEALED THE NEURON MAX WAS KINKED. THIS DAMAGE MAY HAVE OCCURRED DUE TO FORCEFUL MANIPULATION OF THE NEURON MAX DURING ADVANCEMENT. THE TORTUOUS ANATOMY MENTIONED IN THE COMPLAINT MAY HAVE ALSO CONTRIBUTED TO THE DAMAGE ON THE NEURON MAX. FURTHER EVALUATION REVEALED THE ACE 64 WAS STRETCHED AND KINKED. THIS DAMAGE LIKELY OCCURRED DUE TO FORCEFUL RETRACTION OF THE ACE 64 THROUGH THE DAMAGED NEURON MAX. THE 3MAX MENTIONED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. ALL PENUMBRA CATHETERS ARE VISUALLY EVALUATED DURING IN-PROCESS INSPECTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CAROTID ARTERY USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX). DURING THE PROCEDURE, WHILE THE NEURON MAX WAS BEING ADVANCED IN THE PATIENT, IT BECAME KINKED. THE PHYSICIAN DID NOT REPORT ANY RESISTANCE AND DID NOT APPLY ANY FORCE; HOWEVER, IT WAS INDICATED THAT THERE WAS TORTUOUS ARCH ACCESS. DUE TO THE NEURON MAX BEING KINKED, THE ACE 64 AND THE 3MAX CATHETER WERE BOTH STRETCHED WHILE BEING RETRACTED THROUGH THE KINKED AREA OF THE NEURON MAX. ALL THREE DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX, A NEW ACE 64 AND A NEW 3MAX CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62441 PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F64315 00814548013961

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR